Associate Director, Biostatistics

Associate Director, Biostatistics Closed 📅 2 Weeks ago 💰 $197k-$217k 🇺🇸 United States 📊 Data 🔴 Director Job Description Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY The Associate Director, Biostatistics provides strategic input and technical expertise on statistical methodology to lead assigned projects. They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the assigned programs. The incumbent will collaborate closely with cross‑functional teams and external vendors. MAJOR DUTIES & RESPONSIBILITIES: Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies Responsible for the development of randomization schema on assigned randomized studies Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications Responsible for the development of statistical reports summarizing the data analysis results Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials Provide quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate the in-house review comments Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time QUALIFICATIONS: Education: Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience Experience: A M.S. with 7+ years, or PhD with 4+ years in biotech/pharmaceutical industry Experience in ophthalmology and/or biologic/gene therapy a plus Experience with all clinical phases (I, II, III, and IV) is desirable Other Qualifications/Skills: Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines Excellent written and verbal communication skills and strong team player with demonstrated track record of success in cross-functional team environment Travel: <5% Physical Requirements and Working Conditions: Physical Activity